The following data is part of a premarket notification filed by Janco Polymers Pvt., Ltd. with the FDA for Zoetic Gloves.
| Device ID | K905515 |
| 510k Number | K905515 |
| Device Name: | ZOETIC GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | JANCO POLYMERS PVT., LTD. PLOT NO. 18, EXPORT PROCESSING ZONE, KOCHI, KERALA, India, IN |
| Contact | Joseph |
| Correspondent | Joseph JANCO POLYMERS PVT., LTD. PLOT NO. 18, EXPORT PROCESSING ZONE, KOCHI, KERALA, India, IN |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-10 |
| Decision Date | 1990-12-19 |